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Pilot Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets

NCT07412015 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-02-17

No results posted yet for this study

Summary

This is a pilot bioequivalence study. It is a randomized, open-label, single-dose, crossover study. The primary objective of this study is to preliminarily evaluate the pharmacokinetic parameters and their variability of the test formulation versus the reference formulation following a single oral dose under fed conditions.

Conditions

  • T2DM (Type 2 Diabetes Mellitus)

Interventions

DRUG

treatment T (dose 1)

Chiglitazar/Metformin extended-release fixed dose combination tablets (dose 1)

DRUG

treatment T (dose 2)

Chiglitazar/Metformin extended-release fixed dose combination tablets (dose 2)

DRUG

treatment R (dose 1)

Chiglitazar tablets and Metformin extended release tablets (dose 1)

DRUG

treatment R (dose 2)

Chiglitazar tablets and Metformin extended release tablets (dose 2)

Sponsors & Collaborators

  • Chipscreen Biosciences, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-27
Primary Completion
2026-06-29
Completion
2026-06-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07412015 on ClinicalTrials.gov